Hansoh Pharma wins the second prize of National Science and Technology Progress Award, the first time that a Lianyungang company wins the Award as lead winner.
Gemcitabine hydrochloride is the first featured product since the founding of Hansoh Pharma. Since R&D to the birth of the product, the ups and downs and the final success almost pictured the all stages of the company’s initial development.
Gemcitabine hydrochloride is a new oncology antimetabolite drug for the treatment of NSCLC. Clinical results show that it has an efficacy rate of over 40% and is recommended as a first-line drug. The drug was launched in 1995 by Eli Lilly and Company, a US company, and has been under global monopoly being very expensive. In China, NSCLC has the highest incidence rate of all cancers with the number of new cases diagnosed every year around 500,000. Demand for the drug is huge. Breaking technical barrier to produce our own version of the drug has since long been a challenging task for Chinese pharmaceutical companies.
To ensure smooth going of the project, Hansoh Pharma, in cooperation with Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences, began to address technical difficulties one by one. To break technical barrier by originator drug manufacturer, the team worked with Mr. Lin Guoqiang, academician from the Institute, developed various solutions for mass production of the product and constantly optimized them.
After countless days and nights spent in lab and workshop, the team has finally developed a chiral synthesis technology with high stereoselectivity and yield. They employ oligomeric glyceraldehyde-acetonide to replace monomer glyceraldehyde-acetonide used in the original process and optimized reaction conditions, increasing the ratio of main product to by-product from 3:1 to 14:1, the yield from 32% to 51%, and the purity of the key intermediate ribulose from 95% to 99%, achieving mass production of pharmaceutical grade products. The patented process increases product purity and yield as well as quality.
In 2008, gemcitabine hydrochloride was approved by US FDA with “zero defect”, the first time for domestic APIs. In 2012, Zefei (Hansoh’s gemcitabine hydrochloride for injection) became the first domestic preparation approved by US FDA. Hansoh also successfully defended an alleged patent infringement by a foreign company.
In 2011, Zefei’s market share reached 65%, highest in the country. The API, due to its good quality and cheap price, is exported to European and US markets and accumulated foreign earned income exceeds USD100 mm. In 2011, the exports exceeded 1,000kg, accounting for 1/4 of total consumption worldwide. Zefei’s success has driven the growth of Hansoh Pharma and inspired the team to continue its commitment to independent innovation.
Hansoh highly values new product development. Its institute located in Lianyungang, where its headquarter is, has an overall floorage of 35,000 square meters with chemical, biological, preparation development, process, pharmacology and toxicology, and pilot scale experiment departments. It is a nationally recognized enterprise technology center with a number of platforms including state-level postdoctoral research stations, provincial academician workstations, and biomedical high-tech research laboratories. The company has a pharmaceutical chemistry and technology center in Shanghai and a drug information center Since the “11th Five-Year Plan”, the company has undertaken a number of major projects under “Significant New Drug Development”, “863 Program” and “National Innovation Fund”. A number of new drugs under Category 1.1 with independent intellectual property rights have entered clinical research phases of which some will come to market in the upcoming years. The company’s independent innovation capability ranks among domestic top five among its peers. In 2012, it was rated as a “National Technology Innovation Exemplary Enterprise”.
